Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin

Status unconfirmed · Phase 3

Conditions studied: Keratoconus, Corneal Ectasia

In brief

Corneal collagen crosslinking (CXL) has been proposed as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. During the CXL procedure, the central corneal thickness has been shown to significantly change. The investigator's believe that better maintenance of corneal thickness potentially could have benefits of better reproducibility of the crosslinking effect with improved predictability of results.

Key facts

Study ID

NCT01152541

Run by

Cornea and Laser Eye Institute

People needed

160

Starts

2010-06-01

Expected to finish

2025-12-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• A diagnosis of progressive keratoconus over a period of 24 months or less before randomization or a diagnosis of corneal ectasia after corneal refractive surgery
• Vision with contact lenses or glasses is worse than 20/20
• Corneal thickness greater than 300 microns at the thinnest point

You may not qualify if…

• Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
• Corneal pachymetry ≤ 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated.
• Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
• Clinically significant corneal scarring in the CXL treatment zone
• Pregnancy (including plan to become pregnant) or lactation during the course of the study
• A known sensitivity to study medications
• Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.

Where it is running

• Cornea and Laser Eye Institute — Teaneck, New Jersey, United States

Full record on ClinicalTrials.gov

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